User Requirement Specifications

Transcription

1 Page 1 of 15 User Requirement Specifications Tablet Inspection Belt Equipment ID: T-INSB01

2 Page 2 of 15 Table of Contents 1.0 APPROVAL SIGNATURES 2.0 OVERVIEW 3.0 PROCESS DESCRIPTION 4.0 PRODUCTIVITY REQUIREMENT 5.0 SAFETY REQUIREMENT 6.0 GMP REQUIREMENTS 7.0 TECHNICAL REQUIREMENT 8.0 GOOD ENGINEERING PRACTICES REQUIREMENTS 9.0 CONSTRAINTS

3 Page 3 of Approval signatures This document is prepared in line with GMP requirement/ project management of GAPL and same shall be approved by following officials of GAPL. Prepared by Name/ Designation Signature Date Mr. Pundalik N. Dhond, Jr. Officer Production Checked by Name/ Designation Signature Date Mr. B. Demello, Maint. Engineer Approved by Name/ Designation Signature Date Mr. Govind R. Tilve, Manager Production/ESU Authorized by Name/ Designation Signature Date Mr. D.N. Shetty, DGM QC/QA

4 Page 4 of Overview 2.1 Project Standard The facilities, upon completion, shall be in compliance with the cgmp requirement of Drugs And Cosmetic Act-1940/ WHO and also as per the GAPL s internal quality standards. 2.2 Equipment description Inspection belt will be used for Inspection of Coated /Uncoated Tablets. Inspection :- Tablets are automatically passed over vibrator that removes chips and dust from the tablets and feed them on belt after cleaning by nylon brush for first operator to inspect one side of the tablets. These tablets are then automatically passed on to ather belt for second operator to inspect the other side of the tables. Inspection belt consist of SS body, SS hopper and two conveyor belts with other supporting components. Area of installation.l X B X H i.e. 3.8 x 2.4 x 2.5 mtrs. 2.3 Reference standards/guidelines for equipment The equipment should comply with the following guidelines / standard: GMP-Regulations Current Good Manufacturing Practice for finished Pharmaceuticals. Note: 1) This URS has been prepared based on our in-house kwledge & understanding for this equipment. It is possible that certain points might have been overlooked. As a vendor we expect you to go through the document in depth and give your suggestions separately as an option. However, the base offer shall be as per the URS. All suggestions and deviations shall be highlighted and summarized separately. 2) Vendor shall provide response as or No against each specification for the compliance of their offered equipment in the remarks column.

5 Page 5 of 15 Specifications Remarks 3.0 Process Description 3.1 Input & Charging method Coated/Uncoated Tablets are manually transferred into the Inspection Belt Hopper. 3.2 Brief Process Steps The input material will be charged manually The process parameters of the product will be set and verified Subsequent sorting takes place Inspected tablets will be collected in double lined polythene bags. 3.3 Output The output material will be charged manually.

6 Page 6 of Productivity Requirement 4.1 Desired/ suggested capacity 8.00 lacks per shift of 8.0 hrs. Specifications Remarks 4.2 Standard batch size Variable batch sizes tablets Equipment shall be capable of inspecting minimum of 6.0 mm to maximum of 15.0 mm round flat tablets Equipment shall be capable of inspecting minimum of 8.0mm to maximum of 12.0 mm concave tablets Equipment shall be capable of inspecting capsule shape tablets ranging from 15x8 mm to 21x9 mm tablets. 4.3 Change Over Time Vendor to give information on change over time from one product to ather Product 4.4 Cleaning/sanitization Time The equipment shall be easily accessible for cleaning the n-product contact part at maintenance side of the equipment Equipment contact parts shall be easily dismantle and cleanable Cleaning of external product n-contact part shall be done manually.

7 Page 7 of Safety requirement 5.1 General Following facilities must be provided to protect personnel, article and equipment: In the event of equipment malfunction or loss of utilities, the unit must contain all necessary protection devices to ensure that the equipment and the article remain in a safe condition Following operation must be stopped after pressing foot switches. a) Conveyor Belt b) Hopper Vibrator Emergency stop function on all accessible areas Appropriate closure of all the rotating parts. Specifications Remarks Proper earthing of the equipment. 5.2 Power failure and recovery On power failure equipment shall come to rest, to protect operator, equipment itself and the product Power restart must t be automatic and human intervention must be required After regain of power the equipment should start from the step it stopped.

8 Page 8 of GMP requirements 6.1 Process control The equipment must operate and control the following process parameters Foot switcher for each conveyor belt CFL light for each conveyor belt with illumination at one point Magnifying lens of size t less than 5 x 5 inches for each conveyor belt Speed adjustment control for each conveyor belt Vibration adjustment control for Hopper Perforated tray fitted on vibrator to discard the chipped portion of tablets & free particles from the hopper All the settings should be possible to be done from outside without opening the machine Specifications Remarks 6.2 Failure mode detection Equipment shall be capable to detect the following failure and shutdown the process: Emergency stop.

9 Page 9 of Cleaning requirement All bolts, nuts on the exterior part of equipment will be with cap head or cap nut Design of equipment should enhance cleaning feasibility by providing minimum sharp corners, minimum crevices & smooth finished welds joints Parts, which are required for cleaning out of place, should be provided with quick fixing arrangement The equipment shall be compatible to different cleaning agents Quick dismantle of Hopper. 6.4 Qualification requirement General Equipment shall be qualified for design phase (DQ), installation phase (IQ), Operational phase (OQ) and the performance phase (PQ). Specifications Remarks Vendor shall support client in execution of all the qualification phases. 6.5 Material of construction All following metallic critical contact surfaces should be constructed of 316L grade stainless steel. with internal mirror surface finish < 0.5μm Ra All n-product contact metallic surfaces should be constructed of 304 grade stainless steel, external surface finish as matte finish< 1.2μm Ra.

10 Page 10 of Gaskets, seals and O-rings coming in direct / indirect contact surfaces should be constructed of FDA approved polymeric materials (food grade only.) All welds should be ground finished to < 1.2μm Ra and properly passivated Insulation material should be n-fibrous and covered with completely welded SS 304 or better cladding Conveyor belt should be constructed of FDA polymeric material (Food grade only) without any joints in between. 6.6 Use of lubricants Any lubricant, used in the equipment must be of food grade and n-toxic. 6.7 Desired documents Following documents, but t limited to these, are expected from the vendor as part of the supply package Vendor shall supply the document package in phases throughout the life cycle of the project as follows: Phase 1: Preordering of the equipment Filled in URS Equipment layout drawing considering the available space at the installation block keeping adequate space for the operation Detail technical offer that support the compliance of the URS Phase 2: Post ordering and prefabrication stage of the equipment Functional design specification and technical specification, that should contain the following:

11 Page 11 of 15 Equipment descriptions and its function Equipment operation steps List of failure indications List of interlocks List of input/outputs and its functions Specifications Remarks Critical list of major component, devices and instruments with their specific functions, specifications data sheet Schematic diagram of the equipment. Based on the above documents, equipment design shall be evaluated and approved by the user for the fabrication Activity chart of the project Phase 3: Fabrication stage of the equipment Vendor shall provide the FAT protocol at least 1 month in advance of the date of FAT, for the approval by the user Phase 4: Delivery of the equipment Vendor shall provide the following documents in the delivery package in minimum 2 sets. The delivery package shall reach the site of user atleast 15 days before the delivery equipments for the engineering check of the documents Operation and maintenance manuals, preventive maintenance schedule for equipment major component as well as the operating system

12 Page 12 of Operation and maintenance manuals for the bought out items Installation instructions/ guideline for equipment Final as-built drawing for equipment Detailed drawing marking clearly all the necessary dimensions and locations of utilities along with requirement of utilities on the drawing along with the offer Spare and/ or change parts list with ordering information Certificates for MOC of all direct/ indirect product contact surfaces Types of Lubricant and Lubrication instructions. Food grade Certificate Weld verification report Instrument calibration certificates if any Guaranty/ warranty certificates for each equipment and major bought-out items. 6.8 Training Training for operators & technical staff has to be included in the offer

13 Page 13 of Technical requirement 7.1 Basic technical requirement A proposal of a possible installation layout should be added to the documentation The manufacturer has to give the clear details on the total weight and the capacity of the equipment. Specifications Remarks The construction of the complete system should be described in the documentation in detail All revolving parts should be mounted on antifriction thrust bearings Cables, air tubes, etc required from the point (single utility point) to equipment is in scope of vendor Vendor shall provide special tools for maintenance of the equipment 7.2Specific requirements Preferred makes for Motor: Kirloskar / Compton Greaves/ Siemens Two Conveyor belt in the supply scope. 7.3 Utility Requirement Electricity: Consumption details to be provided by Vendor

14 Page 14 of Good Engineering Practices Requirements a. Equipment must be fabricated following all Good Engineering Practices. The vendor s Quality System must follow applicable national standards b. Vendor must generate all applicable documents during all phases of equipment fabrication i.e. design, fabrication, testing and shipment as per applicable standards. c. All sensors, controllers,indicators and will have to be calibrated, Original calibration certificate along with traceability to be submitted by vendor in their IQ file. d. All material of construction should have test certificate e. Vendor must generate and provide all specifications and test certificates of software used in the equipment control and/or monitoring system. 8.1 Inspection and testing a) System shall be inspected and tested (FAT) at the Vendor s site in the presence of user s representative before delivery. b)vendor shall prepare FAT and SAT protocol and get approved from GAPL c) Minimum 3 days shall be reserved for FAT and SAT each and vendor shall ensure the availability of relevant personnel test material and measurement devices.

15 Page 15 of Constraints 9.1 Equipment location and available space This equipment will be installed in the existing available area (Ref.2.2) Floor: Ground Floor Department: Tablet Area : Inspection Area Site visit of vendor preferred for the inspection & confirmation of exact location for new installation.